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Abstract

Background

This pretrial study aimed to develop and test the usability of a four-week Internet
intervention delivered by a Web-enabled mobile phone to support self-management of
chronic widespread pain.

Methods

The intervention included daily online entries and individualized written feedback,
grounded in a mindfulness-based cognitive behavioral approach. The participants registered
activities, emotions and pain cognitions three times daily using the mobile device.
The therapist had immediate access to this information through a secure Web site.
The situational information was used to formulate and send a personalized text message
to the participant with the aim of stimulating effective self-management of the current
situation. Six women participated and evaluated the experience.

Results

The intervention was rated as supportive, meaningful and user-friendly by the majority
of the women. The response rate to the daily registration entries was high and technical
problems were few.

Conclusion

The results indicate a feasible intervention. Web-applications are fast becoming standard
features of mobile phones and interventions of this kind can therefore be more available
than before.

Trial registration number

Background

Behavior change is an integral part of improved self-management of many chronic health
disorders. For people with chronic widespread pain (CWP) or fibromyalgia syndrome
(FMS) this is no easy task. The chronic condition of pain without a clear physiological
explanation often entails a downward spiral of pain, fear of pain and avoidance behavior,
fatigue and depressive symptoms, which makes behavior change extremely challenging
[1]. The development of CWP and FMS involves a complex dynamic biopsychosocial process,
and multidimensional rehabilitation seems to be the most effective treatment approach
[2]. An essential part of the treatment should be an intervention based on cognitive
behavioral therapy (CBT) to increase self-management skills [3,4]. CBT with focus on mindfulness and acceptance processes has been found to be effective
for people with different chronic health disorders [5], including pain [6]. The goal is for the patient to accept, rather than struggle with unwanted thoughts,
emotions and symptoms, and to commit to valued behavior [6,7]. Because of differences in philosophical background and applied techniques between
the mindfulness approach and more traditional CBT, some define the mindfulness approach
as a new generation of behavioral therapy [8] whereas others view it as consistent with CBT [9].

Internet-administrated cognitive behavioral interventions are increasingly used to
support people with health problems [10,11]. Effective operationalization of important elements seems possible because, for some
conditions, the effectiveness of Internet-based CBT has been shown to be similar to
that of face-to-face CBT [10-12]. A recent meta-analysis of 11 studies shows that Internet-delivered cognitive behavioral
interventions for people with chronic pain have a significantly greater effect on
pain level than waiting list conditions [13]. The pooled effect size was small, but all the reviewed interventions also improved
significantly other health-related and behavioral outcomes (e.g., distress and work
capability) compared with the waiting list group.

Results of a recent review of Internet interventions aiming to support behavior changes
indicate that interventions including mobile phone text messages and/or some personal
online contact can be more helpful in supporting behavior change than Internet interventions
without those features [14]. Today's mobile phones commonly include an integrated Internet facility, (e.g., personal
digital assistants (PDAs) and smartphones), which opens new possibilities for Internet-based
CBT. By using a Web-enabled mobile phone instead of a desktop or laptop computer,
the patient can register and send information to the therapist when in different situations.
An important goal of CBT is to improve functioning by detecting how automatic thoughts
influence feelings and behavior [6]. For this purpose, patients are encouraged to keep some form of record of their thoughts,
emotions and behavior (e.g., "What did I feel in the situation?"). The Experience
Sampling Method is a way to obtain information on thoughts, feelings and behavior
in real time with minimal retrospective bias (e.g., "Right now I am feeling...") [15]. Questions in this format can be answered using the mobile phone and may support
self-monitoring [16,17]. The Internet connection makes it possible to submit this information online and
make it immediately available to a therapist. The therapist is thereby provided with
situational information with a reduced risk of memory bias. Importantly, this also
enables the therapist to give the patient prompt feedback on the registered information
via a text message [16,18]. In a randomized controlled trial of 76 patients with irritable bowel syndrome, a
cluster of symptoms without clear organic abnormalities, the intervention group kept
daily online symptom diaries for four weeks and received daily CBT based feedback
on a mobile phone. Compared with the control group, the intervention group showed
improvements in key symptoms such as catastrophizing thoughts and in quality of life.
The effect on catastrophizing was sustained at a three-month follow-up [16]. Using mobile phones and text messaging to support behavior change seems effective
for people with different health conditions [14,19]. To our knowledge, no studies exist on the effect of mobile phone interventions to
support people with chronic widespread pain [20].

The purpose of this pretrial study was to describe the development and usability of
a cognitive behavioral intervention for people with chronic pain using Web-enabled
mobile phones. The mobile phones were used to keep online diaries on thoughts, feelings
and behavior and to receive situational feedback from a therapist. Acceptability,
response rate and user friendliness of the technological system were investigated.

Methods

Study sample

This pretrial study was performed from October 2008 to January 2009 on a convenience
sample. The goal was to include 6 participants diagnosed with CWP or FMS to test the
usability of the intervention. Because women are more often affected by these conditions
[4], the choice was made to include only women in this study.

The original aim was to recruit all participants from general practitioners (GPs)
but letters and phone calls to the GPs' offices resulted in the recruitment of only
two participants. It was therefore decided to contact a rehabilitation center for
further recruitment. At the rehabilitation center, the researchers gave information
about the study to a group of women with CWP participating in a four-week inpatient
multidimensional pain management program including education and pain management in
a cognitive setting, various forms of aerobic exercises, stretching, myofascial pain
treatment, relaxation and medication as needed (see [21] for details of the program). The first four women to contact the researchers were
invited to participate in the study after they had completed the pain management program.
Participants received a letter describing the study (either at a visit to their GP's
office or at the rehabilitation center). The aims of the study were described as being
to develop and implement innovative communication methods to support coping in women
with chronic pain. The participants were informed of the intervention's intention
to increase awareness of the mind and body relationship and support commitment to
valued behavior. Those interested in participating met with the first author and received
more information, and signed an informed consent form.

The intervention

The intervention was developed by building on the experiences of a collaborator (SvD)
using similar technology to support people coping with irritable bowel syndrome [16]. For the technological platform, the Open Source Content Management System (Drupal)
was used. Data security was maintained through a combination of system design, Hypertext
Transfer Protocol Secure (HTTPS) and a proprietary mobile phone authentication system
[22]. The content of the intervention (questions in diaries, feedback content and CBT
exercises) was chosen by the authors, a multidisciplinary group of health professionals.
The theoretical framework was CBT with a focus on mindfulness and acceptance of symptoms.
In addition, identifying and working with values and valued activities was emphasized,
as recommended by McCracken's mindfulness and acceptance-based CBT for people with
chronic pain [6].

Face-to-face meeting

The intervention started with a one-hour individual meeting between the therapist
(a nurse, OBK) and the participant. Each participant was informed about the intervention,
asked about her functioning, her goals for health-related behavior and her need for
support. They received written exercises to do at home (see Table 1) and an audio CD with relaxation and mindfulness exercises developed in an earlier
study [23]. Each participant was lent a Web-enabled mobile phone (HTC TyTN II) with touch screen
and keyboard and made the first diary entry at the meeting.

Online diaries

The participant was asked to complete three diary entries per day using the mobile
phone. At a scheduled diary-completion time, she received a Short Message Service
(SMS) message with a link to a secure Web site where the diary could be opened and
questions answered and submitted back to the server. The morning and evening diary
entries were sent at fixed hours chosen by each participant. The second diary entry
of the day was sent at a time randomly chosen by the Web server, between 11.30 am
and 2 pm. The purpose of including three diary entries, including one at a randomly
chosen time, was to encourage self-monitoring of thoughts and feelings at different
hours and in different situations. No data were kept on the mobile phone [22]. Two reminder SMS messages were sent within one hour if the diary entry was not returned.
If the entry was not submitted within 90 minutes, the form was closed.

The diaries included 19-32 questions. The questions were chosen to support self-monitoring
and awareness of feelings, thoughts related to the symptoms and applied self-management
strategies. The questions were formulated in line with Experience Sampling Method
principles to capture thoughts, feelings and behavior in real time. Most answers were
reported by choosing predefined alternatives or scoring on five-point Likert scales.
The diaries included questions about current level and interference of pain, planned
and achieved activities, feelings, pain-related fear, avoidance, catastrophizing and
acceptance (see Table 2). All diaries included a comment field giving participants the opportunity to write
a short personal message to the therapist. The participants completed diary entries
for a couple of days to get used to the registration, and then they made entries and
received daily feedback for four weeks.

Online written situational feedback

For four weeks, excluding weekends, participants received daily written online feedback
within 90 minutes of completing the second (midday) diary entry of the day. The feedback
was written by a therapist with a M.Sc. in nursing (OBK). The content of the feedback
was supervised by two members of the group (HE, nurse and psychologist with 25 years
experience in teaching mindfulness meditation, and EAF, a medical doctor, psychiatrist
and a CBT therapist and supervisor). Feedback was sent even if the midday diary was
not submitted. The therapist used information from the latest submitted diary. An
SMS was sent to signal that feedback was available. The text messages included a link
to the Web site where the feedback was posted. There was no limitation on the length
of the feedback, which varied from a few sentences to a few paragraphs.

The feedback was intended to suit the participant's situation as reported in the diary.
It was written in an empathic communication style and included positive reinforcement,
information, metaphors, CBT exercises and questions aiming to encourage mindfulness
and willingness to engage in meaningful activities despite pain or other discouraging
intrusions (Table 1). Either the instructions for the exercises were written directly in the feedback
or participants were referred to the written worksheets or the CD. All participants
received feedback texts on values, value-based behavior, mindfulness and acceptance.
The texts were tailored to the personal information given at the face-to-face introductory
meeting and to the information registered in the diaries. See Table 3 for an example of feedback content.

Evaluation measures

Feasibility of the intervention

To measure feasibility, we developed a questionnaire to measure patients' experiences
and satisfaction with the intervention. Participants were also asked to participate
in two semi-structured interviews to explore their experience with the intervention
(halfway through and after completion). The researchers (OBK and HE) met with the
patients individually to evaluate the intervention with questions aiming to capture
the experience of participating and suggestions for improvement. Additionally, the
experience of the therapist (OBK) was summarized.

Subjective usefulness of the feedback

In every evening diary entry, participants were asked about the subjective usefulness
of the feedback by two questions with predefined answers to choose from.

Assessment questionnaires

To measure possible effects on acceptance and pain-related cognitions, participants
were asked to fill out the Chronic Pain Acceptance Questionnaire (CPAQ) [24] and the Pain Catastrophizing Scale (PCS) [25] before and immediately after the intervention period. Catastrophizing and pain acceptance
are concepts that seem to mediate effects on treatment outcome in people with chronic
pain [26,27]. The CPAQ is a 20-item self-reported instrument containing two subscales: Activity
engagement (extent of participation in daily activities despite pain experience) and
Pain willingness (willingness to experience pain without trying to control, alter
or avoid it). It is scored on a seven-point Likert scale from 0 (never true) to 6
(always true) to give the total score (0-120). Higher scores reflect higher acceptance
of pain and higher activities engagement. The PCS is a 13-item questionnaire with
three subscales: helplessness, magnification and rumination. Patients rate items on
a scale of 0 (not at all) to 4 (all the time). The total score range for PCS is 0-52,
with higher scores reflecting higher degrees of catastrophizing. Average pain intensity
(previous week) was assessed on a numerical rating scale from 0 (no pain) to 10 (worst
possible pain).

Treatment fidelity measures

Data were gathered on how many diary entries were submitted by each participant.

Ethical aspects

The study was approved by the Regional Ethical Committee in Norway and by Norwegian
Social Science Services.

Analyses

Descriptive statistics were calculated as means and frequencies using SPSS version
16. Notes from the interviews were compared and themes identified.

Results

Study sample

Six women aged 23-48 years (mean = 36.3) with CWP participated. Four participants
were recruited from a rehabilitation center where they had just completed a four-week
inpatient multidimensional pain management program. Two were recruited from their
GP's office. Three were employed and three were on sick leave. Three were single and
the others were cohabiting. Mean average pain level the previous week was 5.33 (SD
= 1.51) (0 = no pain, 10 = worst imaginable pain). Table 4 shows pain levels and scores on CPAQ and PCS before and after the intervention period.

Evaluation questionnaires

The experience of filling out the diaries was rated as positive and the questions
were rated as easily understood. All participants judged the questions in diaries
and the content of the feedback to be relevant. Most felt that they were able to do
the exercises mentioned in the feedback. All but one participant believed the intervention
had increased their insight into their symptoms, and four out of six felt they had
learned some new methods to cope with their symptoms. None perceived participation
as boring, shameful or invasive of privacy. Most of the participants perceived the
mobile phone as user friendly but two found it too heavy and big.

Table 6 shows that most participants agreed that three registrations and one feedback were
acceptable per day. Most thought the length of the intervention period to be suitable,
but two preferred a longer period. Two women found the number of questions in the
diaries to be too many. One participant reported feeling burdened by the intervention,
and two agreed that it was somewhat disturbing.

Subjective usefulness of the feedback

In every evening diary entry, participants were asked to rate the subjective usefulness
of the feedback using predefined answers. Fifty percent reported the feedback messages
as helpful in maintaining activity (to a level perceived as satisfactory by the participant),
and 76% as helpful in staying emotionally well.

Interviews

The participants appreciated participation in the intervention. They found it useful
to fill out the diaries; it increased awareness of their own reactions to the pain
and it supported the use of positive coping strategies. The feedback messages were
experienced as personal and relevant to the current situation, with a suitable mix
of praise, encouragement and CBT exercises. They considered the exercises helpful
but some found a few of the exercises difficult to understand. One participant said
that she felt she could be more honest when filling out the diaries than she would
have been in a face-to-face setting. One of the participants from the rehabilitation
center said she felt the intervention had motivated and helped her to integrate what
she had learned at the rehabilitation center. It was perceived as supportive in breaking
habits and establishing new health behavior. One mentioned that it had made her prioritize
reflection on important things. Two women wanted a print out of the feedback messages
to have the content available after the intervention.

However, some frustration and difficulties with the intervention were also mentioned.
It was occasionally found inconvenient to take the extra mobile phone along, and to
fill out the diaries. Some experienced problems with submitting the diaries, e.g.
that the registered information disappeared and they had to fill out the diary again.
Two mentioned finding it challenging to report on their feelings in the morning diaries.
Most wanted a bigger comment field to be able to write more to the therapist. One
woman reported sometimes feeling frustrated because she felt misunderstood and was
not able to explain herself. The participants' perception of the intervention did
not change between the interviews.

The participant who dropped out after three weeks did not experience the intervention
as helpful. This woman suffered from flu during the intervention period, something
that may have affected her ability and interest in participating.

Response rate and technical issues

Five patients completed the pilot study. They had a mean response rate of 88% (range
78-94%) to the diaries. One woman recruited from general practice dropped out after
three weeks (but still gave her evaluation). Her response rate to filling out the
diaries was 42%.

Some experienced a few temporary problems with the Internet connection. It was reported
to be frustrating to have filled out a diary form and then not be able to send it
because of a validation error. This happened occasionally when the Internet connection
was poor, and the validation process from the mobile phone to the server took too
long; access was then denied to ensure data security. The researchers were contacted
on a few occasions because of problems with submitting a diary form caused by "bad"
Internet connections. One feedback message was sent to the wrong participant because
the therapist clicked on the wrong feedback button in the system. We had one system
breakdown during the pilot period. The system was restored to working order in a few
hours and only the submission of the midday entries on one day was disturbed; the
evening diary entries that day were completed as usual.

The therapist's clinical impression

The therapist's experience was mainly positive. She felt that an interactive relationship
was established with most of the participants. Nevertheless, the goal of always being
empathic and accepting without encouraging avoidant behavior was sometimes found challenging
without the ability of providing empathic nonverbal signals and dialog. On occasions,
the therapist missed not being able to experience the reaction to questions and statements
written in the feedback, especially when metaphors were used to stimulate reflection
on values or other exercises anticipated to be emotionally demanding. When a participant
reported a high pain score and a low mood it was sometimes tempting to reply with
empathy only and not to confront and provide possible challenging questions and/or
exercises. The participant's evaluation of how helpful the most recent feedback had
been was useful. It might have been beneficial to have the possibility to refer to
audio descriptions of more mindfulness exercises (preferably accessible on the mobile
phone).

Before writing a feedback message, the therapist would view the three diary entries
since the last feedback was sent. It was also necessary to look at the feedback history
(all feedback messages were saved on the Web site) to ensure variance in the recommended
CBT and mindfulness exercises and to avoid repeating information. No strict feedback
template was followed and the amount of time used per feedback varied. Generally,
15-20 minutes were used, with the time decreasing somewhat with experience and the
ability to copy and paste content between participants from the growing "bank" of
previously written feedback messages.

Discussion

The aim of this pretrial study was to test the feasibility of delivering an online
intervention on a mobile phone and to investigate its acceptability to women with
chronic widespread pain and to providers. The intervention was mainly considered user-friendly
and helpful, indicating a feasible intervention. The format of the diaries was well
accepted and the response rate was generally high (> 80%). This is in accordance with
response rates from other studies using electronic diaries [28,29]. Most participants rated the intervention as meaningful and some improvements were
shown on measures of catastrophizing and pain acceptance. However, because of the
small sample size, these results are of limited value. It should be kept in mind that
four out of six women had participated in a rehabilitation program prior to the intervention.
It needs to be mentioned that the nurse writing the feedback was also involved in
the evaluation interviews and this may have affected the evaluation results. The intervention's
framework of mindfulness-based CBT was considered acceptable but further studies are
needed to investigate effectiveness and possible therapeutic processes.

Two of the women found some aspects of the intervention disturbing, frustrating and
even difficult, e.g. found it challenging to report how they were feeling. Restricted
emotional processing and a higher prevalence of alexithymia in patients with FMS than
others has been indicated [30]. If and how this could affect the perception and outcome of this intervention needs
to be explored.

Recruitment from GPs was not successful and only a few GPs responded to the invitation
to include patients in this study. This is not an uncommon experience for e-health
interventions [31] or health research in general [32]. Recruitment from the rehabilitation center was more successful. In addition, the
experience of the participants from the rehabilitation center was more positive than
that of the participants recruited from the GPs. Despite originally intending to recruit
only from GPs, it was the impression of both the researchers and the therapist that
the intervention might be more accessible following completion of a clinic-based program
rather than as an independent intervention. Therapist time per participant was estimated
to be about 6-8 hours (including initial meeting and 20 feedback messages). Therapist
time is expected to decrease with the construction of a feedback "bank". The predicted
economical cost of the intervention is greater than for Web-based interventions with
no therapist support. However, results comparing Internet interventions with and without
therapist support indicate that the role of an identified therapist has important
added value for influencing adherence and outcome [33].

The results from this pretrial study indicate that some possible improvements could
be made to the intervention. A few temporary problems with submitting diary entries
occurred and should be addressed as they may cause frustration and affect dropout
rates. Changes need to be made to eliminate the possibility of sending feedback to
the wrong participant. A reduction in the number of items per diary entry might increase
acceptability even further [28]. The possibility of participants using their own mobile phones instead of borrowed
ones would be preferable. The content of the supplementary audio CD and worksheets
could be made available on the participant's phone. Furthermore, to be more consistent
with the mindfulness-based CBT framework the audio files should include only mindfulness
exercises and not relaxation training. A structured theory-based feedback protocol
could make replication of results more feasible, but might compromise the tailored
situational aspect of the feedback.

Conclusions

The results of this pretrial study indicate that written online situational feedback
via mobile phone is a feasible intervention for women with chronic widespread pain.
The intervention will be further tested in a randomized study to investigate therapeutic
effectiveness on behavior change. Web applications are fast becoming standard ingredients
in mobile phones and CBT interventions of this kind can be more readily available
than before.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

All authors participated in the development of the intervention. OBK recruited participants,
helped by SHW who was responsible for Rehabilitation Center patient diagnostics. OBK
performed the role of the therapist and participated in evaluation data collection.
HE coordinated the study, participated in evaluation interviews and supervised data
from participants and feedback. EAF supervised data from participants and feedback.
EE was responsible for the design and development of the technological system. OBK
and HE analyzed the data and drafted the manuscript. All authors read and approved
the final manuscript.

Acknowledgements

The study is funded by the Research Council of Norway (grant number 182014).

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